Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Eszopiclone; Drug: Escitalopram; Drug: Placebo

Detailed Description

This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline

Exclusion Criteria:

• May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eszopiclone; Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg	Drug: Eszopiclone; Eszopiclone 2mg daily at bedtime; Other Names: Escitalopram 10mg or 20mg daily in the AM; Drug: Escitalopram; Escitalopram 10mg or 20mg
Placebo Comparator: Placebo; Drug: Placebo, Drug: Escitalopram 10mg or 20mg	Drug: Escitalopram; Escitalopram 10mg or 20mg; Drug: Placebo; Placebo daily at bedtime; Other Names: Escitalopram 10mg or 20mg daily in the AM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total sleep time from baseline to final visit	from baseline to final visit

Secondary Outcome Measures

Outcome Measure	Time Frame
change in sleep latency from baseline to final visit	from baseline to final visit
Change in HAMD from baseline to final visit	from baseline to final visit
Change in ISI from baseline to final visit	baseline to final visit
Change in CGI-S, CGI-I from baseline to final visit	baseline to final visit
labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height	visit 1
vitals: BP,pulse,temperature,weight,assess AE's/SAE's	every visit

Collaborators and Investigators

• Sponsor: Lehigh Center for Clinical Research
• Collaborators: Sunovion
• Investigators: Principal Investigator: Paul K Gross, Lehigh Center for Clinical Research

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Insomnia; Geriatric; Major Depression
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depressive Disorder; Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Hypnotics and Sedatives; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide; Eszopiclone
• Other Study ID Numbers: ESRCO66